Use cautionMedical device recall · FDA · Published October 25, 2025
Fresenius Medical Care 5008X CAREsystem Recall: Software Anomalies Risk Treatment Stop
Fresenius Medical Care recalls 5008X CAREsystem devices with software versions before 4.82.4 due to potential treatment stop risks. Affected units may require software updates to prevent patient treatment interruptions.
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Take action
Contact the company
📍Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521
“Fresenius Medical Care 5008X CAREsystem Recall: Software Anomalies Risk Treatment Stop.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51000-fresenius-medical-care-5008x-caresystem-recall-software-anomalies-risk-treatment. Based on FDA recall #Z-0936-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0936-2026%22&limit=1).
The FDA announced on Oct. 25, 2025, that Fresenius Medical Care Holdings, Inc. is voluntarily recalling 5008X CAREsystem +CLiC +CDX dialysis devices due to software anomalies that could stop treatment. According to the FDA, owners should contact the company for a remedy.
How to tell if you have it
Brand: Fresenius Medical Care
Product: 5008X CAREsystem +CLiC +CDX
Model Number: M204441
UDI-DI: 00840861102433
Software version: prior to 4.82.4
Units affected: 115
The hazard
According to the FDA, several software anomalies with the potential to impact patient treatment exist in the recalled devices. One anomaly includes the possibility of resulting in treatment stop if certain conditions are fulfilled.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls of similar products include Fresenius Bicarby Dialysate Leaks Risk (May 12, 2026), Fresenius 5008X Blood Tubing Set Recall (May 11, 2026), and Fresenius Medical Care Bicarby Dialysate Recall (May 7, 2026). Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (Nov. 14, 2025), GE Medical Systems Portrait Compute V1.2 Software Recall (July 20, 2026), and Philips Patient Information Center iX Software Freezes - Recall (July 31, 2026).
How to tell if you have this one
Check if your device has a model number M204441 and a software version older than 4.82.4. The recall covers all units with serial numbers produced before a specific software version.
Brand
Fresen:ius Medical Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your device's software version; if it's older than 4.82.4, it's affected.
Contact Manufacturer
Reach out to Fresenius Medical Care for guidance on updating software or other remedies.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “Domestic: LA, MA, MN;” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Louisiana, Massachusetts, Minnesota.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0936-2026 (October 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0936-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.